November / December 2012
Drug Shortages and Emergency Care: Your Action Is Needed
An unprecedented, unexpected, and unplanned shortage of emergency medications has resulted in a quickly expanding set of problems for emergency departments (EDs) and emergency medical services (EMS) systems. The causes of this shortage are poorly understood, but the manufacturers and federal agencies that oversee drug supply and manufacturing practices—Federal Drug Administration (FDA) and Drug Enforcement Administration (DEA)—have been at odds for the past few years over safe manufacturing and quality processes. In certain circumstances, problems in the supply chain for raw materials for drugs cause shortages; for example, some raw materials come from overseas sources and may be subject to factors such as wars, weather, and problems with supply. Medication shortages are affecting many specialties, including oncology and anesthesia, but the emergency care system is particularly at risk for patient safety issues.
The problem, and its rapid evolution over the past 8 months, have resulted in publications from the FDA and the Government Accounting Office (GAO); a position statement from the International Association of Fire Chiefs; and action by the United States Metropolitan Municipalities Emergency Medical Services Medical Directors Consortium (known as “The Eagles”). There is unanimous agreement that present and looming shortages of common emergency medications threaten patient safety.
Scope of the Problem
The critical shortage affects medications across all classes of emergency medicines, including those that control pain, sedate, restore heart function, treat anaphylaxis, and care for common emergencies in children. As of August 1, 2012, there were shortages of 163 preparations of 59 different drugs in the emergency care field alone.
Because of the relatively high costs and short shelf lives of emergency medications, there are thin stocks of emergency medications within the emergency system. Hospitals may not be able to re-supply or exchange medications with EMS providers due to some interpretations of federal kickback rules, and EMS personnel have limits on therapeutic substitution of other medications.
Critical medications often have no alternatives or have delivery packaging that is difficult to replicate for emergency providers working in austere environments in the ED and outside the hospital. Without access to the preferred or most clinically appropriate drug treatment, ED and EMS personnel may be forced to use alternatives that are less effective and may have an increased risk of adverse outcomes.
What Emergency Leaders Need to Know
Emergency physicians and ED directors should be well-versed on the medications in short supply, and how they are affecting their own EDs. Crisis monitoring websites maintained by the FDA (http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.htm) and the American Society of Healthcare Pharmacists (ASHP; http://www.ashp.org/) have highlighted the rapidly expanding numbers of medications that are unavailable or in short supply. Not only are emergency medications in short supply to emergency workers, but also critical is the shortage of epinephrine in auto-injector form as a prescription to patients, parents, and schools.
What Is Happening to Solve the Problem
In the absence of effective guidance from federal regulators and the pharmaceutical industry, states must provide guidance, regulatory provision, and support for incident action plans at state and local levels. Since they are most susceptible to the shortage, many EMS agencies have been working collaboratively to address the patient care implications of this shortage. The life-saving medications that are used daily by EMS agencies and cannot be replaced readily must be accessed in novel ways, and many are calling on hospitals and EDs to address the problem. Emergency physicians must be supportive of efforts by EMS personnel to obtain critical supplies of epinephrine, atropine, bicarbonate, magnesium sulfate and others.
Some EMS agencies have moved ahead to develop incident action plans and incident management teams. Outlined strategies will be needed as medicine shortages come to effect patient care. Plans should allow for phased activation. For example, some elements of the plan will be activated in Phase One in response to the potential for significant medication shortages impacting patient care. Phase Two will be activated in stages based on the shortage of medication having a negative impact on EMS operations. Phase Three will be implemented when shortages significantly impact patient care in the field and in hospitals. A phased approach creates the flexibility to react based on a dynamic situation and ensures that EMS agencies and hospitals act cooperatively with local, regional, and state response strategies.
What Emergency Leaders Need to Do
On a day-to-day basis, emergency physicians and nurses need to be aware of drug shortages in their ED and among local EMS providers. If ED physicians and nurses are using substitute medications that are not in the usual practice, extra safety notifications should be sent to all personnel to facilitate good patient care. For example, if pain medicines are restricted, ED leaders should update the staff on available pain medications and available dosages, what IV medicines have compatibility issues, and side effects. Some EDs are putting up safety cards in their medication rooms so that staff members have an immediate visual prompt.
If EMS agencies are short on medications, all ED staff members need to be made aware. For example, if the only available sedative is midazolam, and only in 10 mg vials, they may have to waste extra medicine in almost every patient use. It will help if ED physicians and nurses are aware that EMS personnel will need assistance in documenting the process of disposing of the extra, unused medication.
At the system level, emergency physicians should be aware that federal agencies are being petitioned by organizations such as the American College of Emergency Physicians (ACEP) to develop immediate resolutions. In the absence of federal leadership, emergency physicians will need to act at the state and local level. This crisis requires coordinated actions by the office of the governor; the state emergency management agency; and the state boards of pharmacy, health, EMS, and medicine.
State action may have to include disaster declaration, which would allow state and local authorities to create and maintain incident management teams and action plans that promote safe and effective emergency patient care. A disaster declaration will also provide relief from certain federal and state regulations that restrict sharing of medications and resources. It will allow the ED and EMS systems to use available medications that are currently stocked at hospitals and in emergency caches designed for disaster relief. Emergency physicians and nurses can support this effort by reporting to their ED director any cases in which they are involved that are affected by these drug shortages.
Examples could include:
• Patient presents in anaphylaxis, and no auto-injector is available.
• Patient presents via EMS needing additional doses of emergency medications on arrival.
• Patient in ED with adverse affect from second-tier emergency medication.
• EMS personnel not being allowed to replenish their store of emergency medication used during transport of a patient to your ED.
• Patient status post-anaphylaxis leaves the hospital without auto injector in hand from hospital pharmacy.
• Inadequate pain control during sedation for ED procedure due to use of second-tier drug.
Emergency providers should be aware of the implications of medication shortages and participate in the development of action plans for ongoing safe and effective emergency care.
Beginning with this issue, the Emergency Medicine Patient Safety Foundation (EMPSF) will contribute a regular column to PSQH. For more information about EMPSF, please visit www.empsf.org.